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Posted On: 02/10/2021 11:18:32 AM
Post# of 148902
“If CD12 is an adaptive trial, can the 42 day mortality be added as an endpoint even through the 75% DSMB recommendation path was not taken?”
In a scenario where the 28 day primary endpoint fails but a reduction in mortality at 42 days is statistically significant, I believe CYDY would still have a strong case for an EUA/full approval. We cannot know for sure, but it’s likely CYDY requested mortality data at 42 days to be included in the unblinded data.
In a scenario where the 28 day primary endpoint fails but a reduction in mortality at 42 days is statistically significant, I believe CYDY would still have a strong case for an EUA/full approval. We cannot know for sure, but it’s likely CYDY requested mortality data at 42 days to be included in the unblinded data.
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